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    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 17, 2016

    CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·January 30, 2016

    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·February 5, 2016

    Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code OUG·April 4, 2016

    Merge Cardio with software version 10.1 LA.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·October 26, 2015

    RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560, 5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·December 17, 2015

    eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·August 28, 2014

    Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·January 30, 2016

    Merge HEMO software.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code DQK·July 2, 2012

    Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·October 8, 2015

    Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·January 30, 2016

    Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 9, 2016

    DR Systems Unity PACS software, now known as Merge Unity PACS software.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·October 15, 2015

    iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LMB·January 30, 2016

    SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code DQK·April 4, 2016

    The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code DQK·March 10, 2016

    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·January 31, 2016

    Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·October 20, 2016

    Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code DQK·April 6, 2017

    Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 9, 2016